Clearance Summary
AUTOMATIC POSITIVE BEAM COLLIMATOR received FDA 510(k) clearance under submission number K791504, sponsored by Dial-X Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1979-09-07.
- Submission: K791504
- Applicant / Sponsor: Dial-X Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1979-09-07
Classification & Regulation
This clearance is catalogued under FDA product code KPW and 21 CFR 892.1610, within the Radiology review panel as a Class II device.